VIDAS D-Dimer Exclusion II 의 안전성 경고

Safety alert

2013-04-16

2013-04-16

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130416b.html

Medical device safety alert: biomerieux vidas d-dimer exclusion ii medical device manufacturer, biomerieux, has issued a field safety notice concerning the vidas d-dimer exclusion ii [reference no.: 30455 and 30455-01]. the manufacturer has registered some customer complaints about not reproducible results below the detection limit (<45 ng/ml) on the above listed lot numbers. the manufacturer’s internal investigation after testing in-house titrated samples has not reproduced this result. the potential risk associated to this issue is reporting false negative results for vidas d-dimer exclusion ii. the impact of a false negative d-dimer test result could be critical for the patient with a low or moderate clinical pretest probability for deep vein thrombosis (dvt) or pulmonary embolism (pe) because it could prevent further diagnostic workup for venous thromboembolism and withholding anticoagulant treatment when it is actually needed, resulting in a negative impact to patient care. the manufacturer advises all affected users to take the following actions:- repeat all results less than < 45 ng/ml obtained with the kit vidas® d-dimer exclusion ii™ ref. 30455 and 30455-01. determine if retrospective analysis of results of the patients is required and investigate further (e.G. final diagnosis and clinical status of the patient) if the result is < 45 ng/ml. an additional insert will be added to newly manufactured lots to require a confirmation of the results below the detection limit (< 45 ng/ml). according to the local supplier, the affected devices were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 april 2013.